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Topics that shareholders would like to be more informed about from Amarin Press releases...
-questions about a settlement with Healthnet
- questions about the need to pay royalties to Mochida for MND-2119 and if/when to apply for FDA approval of same
-questions about differences between the gelatin capsule and ingredients of Vascepa as opposed to gV
NRx of Vascepa(which has been proven effective in reducing CVD)=29,685
NRx of Lovaza(which has been proven UNeffective in reducing CVD)=31,008
This is further evidence that Docs and patients prefer low price over high efficacy.
Bring on the Vascepa AG!!..As the old saying goes....Amarin may lose a little on every sale, but they can make it up on the volume.
Captain and North...Amarin and Mochida were both relatively small pharmas in 2018....$2.7million was not a pittance for Amarin to pay Mochida at that time (Amarin was still working on the R-IT study)...and, not a pittance for Mochida to receive for collaboration with Amarin on past and future EPA products.
Vascepa had already been commercialized at that time by Amarin and MND-2119 had not yet been invented by Mochida.
Capt...QUOTE..."Amarin WILL pay Mochida a non-refundable, non-creditable upfront payment of $2.7 million, and 'MAY BE' obligated to pay milestone payments and royalties on net sales of future products arising from the collaboration, if any."
Amarin mentioned the royalties in their PR saying"THEY MAY BE OBLIGATED "to pay royalties" rather then saying"THEY WILL BE OBLIGATED" to pay royalties.
This is an important distinction, which Amarin made in their vague PR, and which needs be made more clear, especially as MND-2119 comes into focus.
ILT...QUOTE... "In a bizarre way, perhaps doctors expect complexity to reflect their sense of self importance and wanting to prescribe solutions that match. Prescribing something from fish oil could be seen as low browed, something a naturopathic doc would recommend, but not Mr. Cardiologist."
I agree....Amarin cancelling Vascepa, which has been often described by detractors as a "just a fish oil"...and replacing it with to a new, superior and scientifically named statin-EPA drug for once a day use, would provide an enormous boost to the product in the minds of patients and Docs.
RMB... "The collaboration agreement is focused on the development and commercialization of early-stage drug products based on omega-3 acid EPA (eicosapentaenoic acid)"
I believe the only new product that fits this description would be MND-2119....It is also probable that the agreement would include a future fixed dose combo drug with a statin and MND-2119.
ILT...QUOTE..."On June 12, 2018, Amarin announced that it had entered into a collaboration agreement with Mochida Pharmaceutical Co., Ltd. (“Mochida”), an
integrated Japanese pharmaceutical company. The collaboration agreement is focused on the development and commercialization of early-stage drug products
based on omega-3 acid EPA (eicosapentaenoic acid). Under the collaboration agreement Amarin will, among other things, obtain an exclusive license to
certain Mochida technology to develop, manufacture and commercialize new drug products that contain high purity EPA for the United States and other
territories. Under the collaboration agreement, Amarin will pay Mochida anon-refundable, non-creditable upfront payment of $2.7 million, and 'MAY BE'
obligated to pay milestone payments and royalties on net sales of future products arising from the collaboration, if any."
Vascepa had been commercialized by Amarin prior to the 2018 agreement with Mochida..I was always under the impression that Amarin had paid Mochida $2.7 million in lieu of royalties on sales of Vascepa..If you have information to the contrary, I would appreciate you posting it.
Questions to Amarin re MND-2119 ...
-Will the FDA approve MND-2119 on the basis of studies in Japan?
-Will MND-2119 contain 2 or 4 grams of EPA?
-will MND-2119 be issued as a solo drug or as a combo drug with a statin
-will the USPTO award a patent for MND-2119 as a new drug?
will the USPTO award a patent for the statin MND-2119 fixed dose combo drug as a new drug?
-will Amarin be obligated to pay royalties to Mochida for MND-2119?
-will Amarin retire Vascepa as as a branded drug when MND- 2119 or the fixed dose combo are marketed?
duke....Amarin badly needs a new patented product for the U.S
Both for U.S. and for ROW, Amarin needs a low priced generic Vascepa.
golf..IMO there are too many variables to make an accurate prediction at this stage...However, I do think that Amarin will eventually be sold for a price per share in the double digits.
In Q1 of 2023. I expect...
-a proxy vote to be sent to shareholders by Denner, pursuing control of the Amarin BOD
- an announcement by management that a fixed dose combo approval by the FDA is now being pursued
-an announcement that an approval of MND-2119 is being pursued
- an announcement that an AG of Vascepa is being pursued with the FDA
-an announcement that Amarin is having exploratory discussions about a sale of the company to a BP
JROON...I understand that Viatris is now selling Lipitor...I'm nor sure whether PFE has sold the rights to the name,"Lipitor"...If so, they might still be able to sell "Atorvastin",which is off patent...unless PFE has sold that right also.
I now take 4 capsules of Vascepa plus 6 other meds each day, not counting vitamins...Taking 8 capsules of Vascepa daily would be a real turn off for me...and I suspect, for many others.
JRoon....Under the aegis of PFE,The fixed dose combo containing a statin and EPA(MND-2119) could be given a brand name...something like Epastatin, which would have the benefit of being not only a superior drug for treating CVD, but one, which would be protected by patent....The image of EPA being "just a "fish oil" would cease to be an issue which has been so commonly used to discredit it.
In the ensuing months after release of R-IT results, JT would not consider an offer of less than $40-$50 per share...This was a mistake in retrospect...(at the time, it seemed like a fair price)
Amarin,with the price as low as where it currently is...is now prepared to take less.
ILT...I agree...It would make sense for PFE to develop a FDC with Lipitor and MND 2119 and promote in the U.S. and ROW.
Raf should be granted free shares each month instead of the current management.
Amarin wants to conserve cash and does not want to pursue expensive law suits against well healed insurance companies like BCBS...If a BP were to acquire Amarin, they would have no such hesitation.
IMHO KM came into a difficult situation when he became CEO of Amarin...He has done a good job with what he had at hand...If Amarin were to be sold to a BP, it would make sense to keep KM as CEO of the Amarin subdivision of that BP... Vascepa and Amarin would then flourish as a division of the acquiring BP This success would afford KM an opportunity to become CEO of the BP or some other BP at a future date.
KM has much to gain from a sale of Amarin to a BP being orchestrated by Denner.
If there is any chance of Amarin issuing a FDC drug (with statin plus MND-2119), we need to hear details about it NOW...before Amarin stock price drops still further!...The patented gelatin capsule will apparently not be coming to the rescue of Vascepa ...Something more is needed...and the good news is that it is available from this combo drug.
This new patented drug is Amarin's main opportunity to take itself out of the doldrums and redeem itself, recapturing the AMERICAN market with a superior and less expensive formulation of EPA.
Its a pity that Amarin management did not embark upon a pursuit of this new drug long ago when Craig Granowitz was chief of R and D.
QUOTE..."curiously he left out the secret coming in the next 3-6 months ahead...I’m very surprised that the message boards haven’t exploded trying to decipher that but I think we all know it’s the combo "
A combo would be most effective if it contained a statin plus MND 2119 ...what is holding up Amarin from applying for an FDA approval of this product?
KM, at the Jeffries CC, seemed to indicate that Amarin wanted to see sales in Europe increase before Amarin would entertain bids for a BO...Its more of a question of the size of a bid by the buyer than the need for a hasty sale by the seller.
Per Wold Olsen recently, rapidly appointed two new members to the BOD....possibly in response to Denner's challenge.
These new members will now owe fealty to Olsen in any future negotiations with DENNER.
This means that Denner will have to work harder to get to an agreement with a majority of the members of the BOD, if and when Olsen agrees to give him a seat on the BOD.
Amarin now needs to swing into action...
-introduce an AG and price it similar to Vascepa
-introduce a branded MND 2119
-introduce a fixed dose combo with a statin and MND 2119
Germany is in the process of going through some really tough economic problems...In these times, regulators have to look at the situation from a financial perspective as well as a from a scientific perspective...These regulators may have different points of view...However, patients' serious CVD afflictions, which can be very expensive and even lead to their deaths, should be the most important consideration of the two.
Retinadoc...QUOTE.."She noted that more mechanistic and clinical data are needed to hone in on which patients will derive the most benefit, such as those with elevated high-sensitivity C-reactive protein or highest change in EPA levels."
Consequent to judge Du's decision, which paved the way for infringement of the Vascepa CVD indication by generics, Amarin does not now and will never have sufficient assets to do what Dr. Taub is calling for...The infringing generics have no interest in doing these studies....The only way for these studies to be implemented is for Amarin to be sold to a BP.
I used to write down the numbers of the posts that I wanted to revisit....Now the column to the left of the listed posts has been replaced by a "likes" column, which I find far less useful than the numbers column used to be.
Pdude...I agree...The argument that a difference of .0047 from Stat Sig in the Respect study flies in the face of all the positive studies that have shown Vascepa to be effective at reducing the incidence of CVD.
The detractors of Vascepa were hoping for a negative result from the Respect study and they came up short.
The main thrust of the Respect study was to debunk the canard that the MO placebo used in the Reduce-It study was the source of the excellent results wherein Vascepa showed a reduction of CVD.
The Jelis study had not used a MO placebo, but the myth that MO playing a role in the positive results of Reduce-It was still bandied about(even though Jelis seemed to prove otherwise)....the Respect study also did not use a MO placebo and the results were very similar to those of Jelis...This should put the MO matter to rest for all unbiased observers.
In the face of positive results from the Respect study, Nissen is doing his very best to continue to disrespect Vascepa....in spite of positive values from ALL of the following studies...
-Jelis
-Reduce-it
-Cardiolink
-Cherry
-Evaporate
-Respect
I doubt that Nissen will ever cease fire in his fight against Vascepa....no matter whether Mitigate or any other study in the future finds positive results which corroborate the positive results ALREADY established for Vascepa.
Can you imagine what Nissen would have opined if the results of ANY of these studies had come out negative for Vascepa?
He might then be advising his sponsor, Astra Zeneca, to invest another billion dollars in his failed fish oil. Omacor.
ILT...Apparently the courts have decided that unless the generic companies print "this treatment is for heart attacks and strokes" on the label of their gV, they can't be blamed for infringing......even though anyone, who cares to be informed about what is actually happening, is aware that there is massive infringement going on...This includes infringement by insurance companies among others....Perhaps the Amarin vs. Healthnet suit will afford some solution to this injustice.
Rose...QUOTE..."WHAT is Amarin waiting for to bring out an AUTHORIZED GENERIC DAMN!!"
Amarin is waiting for an increase in volume, sufficient to enable them to lower Vascepa prices below those of the generic companies, which are already armed with exclusivity contract agreements with PBM's for their own multiple generic products...then Amarin can lower their prices enough for an Amarin authorized generic Vascepa to be able compete successfully with fake generic ICEs
...Where is this mega increase in volume going to come from?...It will not be from the U.S. as long as Nissen and Feuerstein hold sway....Perhaps it will come from China.
When/if Vascepa begins to be marketed in mainland China, it will be at lower prices than are presently charged in Europe or in the U.S.
When/if that happens, Amarin will start marketing an authorized generic Vascepa in the U.S....Vascepa will be sold in much higher volumes, leading to lower prices paid by Amarin for API and for finished product...as opposed to the prices available to generics...It will be very difficult for those multiple generics to compete on price and still make money... This is even if they continue to offer lower prices for EXCLUSIVITY deals for all their own generic products to pharmacy benefit plans, as they do now, so that these PBMs will carry all their products... and FREEZE out competing generics FROM OTHER COMPANIES.
At that point Vascepa becomes a global blockbuster, albeit at lower prices.
Skipper....Quote "V was prescribed off label for most of its existence."
This was before Judge Du warned Hikma that Amarin's CVD patent was valid and that gV should be prescribed ONLY for the very high triglyceride indication.
What has happened recently with generic companies and insurance companies have made judge Du's warnings into a sham.
JRoon...You are probably correct... but it is still more evidence that the deceitful BOD needs to be reorganized to put the interests of the shareholders ahead of the interests of the board members, which has unfortunately not been reflected in the practices of the board in the past.
JRoon...ordinarily I would agree with you...However the context in which these grants were made is quite different...Denner had already put the BOD on notice that he intended to distribute a proxy to all shareholders...with the aim of a reorganization of the BOD....Before he had a chance to complete this, and before the shareholders could have a voice, the BOD appoints two new board members and pays them unusually generously....This is, at the very least, contrary to the interests of the shareholders and, as such, an abuse of power....My question is...Is this just a deceitful strategy or is it illegal as well?
Was this a parting gift that the BOD gave to themselves at this critical point in time, being well aware that there was an imminent action by Denner to have the BOD removed?
Is there any legal action that we and other shareholders could take to have these shares returned to the Amarin coffers?
This seems like a flagrant and illegal abuse of power by the BOD and If there is a legal remedy available, I would like to support it.
R and D of new drugs is a very expensive proposition....The U.S., as the richest country in the world, is the place where this can be done profitably.
When Judge Du did her thing on Amarin, a small company with one product, Amarin then became akin to the Rodney Dangerfield of Pharma...Whose complaint was always..."I get no respect".This predicament allows people like Nissen and countries like Germany to constantly crap on Amarin.
Amarin is now a quasi start up, which needs to either capture the U.S. market through marketing MND-2119, or to be sold to a BP which can do it better....Dr. Denner is the best person to explore these avenues.
A small study of the potential ability of Vascepa to prevent colorectal cancer has been going on at the Mass General Hospital in Boston for 2.5 years...A BP could run a larger and longer phase 3 study to see whether Vascepa was preventative of colon cancer in patients with adenomas of the colon.
June 12, 2018 05:00 ET | Source: Amarin Corporation plc
BEDMINSTER, N.J. and DUBLIN, Ireland, June 12, 2018 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today that it has entered into a multi-faceted collaboration with Mochida Pharmaceutical Co., Ltd. (“Mochida”, TYO:4534), an integrated Japanese pharmaceutical company. The collaboration is focused on the development and commercialization of early-stage drug products and indications based on the omega-3 acid, EPA (eicosapentaenoic acid). Amarin and Mochida are recognized worldwide as the leading, innovation-driven companies committed to the research and development of EPA-based drug products to treat the needs of tens of millions of patients who are at-risk of cardiovascular disease.
Amarin developed and markets Vascepa® (icosapent ethyl) capsules in the United States, the first and only FDA-approved, prescription pure EPA drug product. Vascepa is indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Amarin's clinical development program for Vascepa includes the REDUCE-IT cardiovascular outcomes study, an 8,175-patient study commenced in 2011.1 REDUCE-IT is the first multinational cardiovascular outcomes study evaluating the effect of prescription pure EPA therapy, or any triglyceride lowering therapy, as an add-on to statins in patients with high cardiovascular risk who, despite stable statin therapy, have elevated triglyceride levels (150-499 mg/dL). Amarin expects to announce top-line results of this landmark study before the end of Q3 2018.
Mochida is an integrated Japanese pharmaceutical company that developed and markets a prescription pure EPA drug product, Epadel, as a treatment for hyperlipidemia and arteriosclerosis obliterans in Japan. Mochida sponsored and successfully completed a cardiovascular outcomes trial with Epadel in Japan, JELIS. JELIS was the world’s first large-scale randomized controlled cardiovascular outcomes trial of a prescription pure EPA drug product and showed beneficial effects of the drug in further reducing cardiovascular events in statin-treated, hypercholesterolemic Japanese patients.2, 3, 4
“We are excited to enter into a collaboration with Mochida given our common mission to create preventative healthcare solutions on a worldwide basis, and our mutual commitment to continued innovation in the EPA research and development area,” stated John F. Thero, president and chief executive officer of Amarin. “This collaboration seeks to leverage the decades of successful research and development experience at Amarin and Mochida towards expediting the development of new products and indications.”
“Mochida is delighted to partner with Amarin,” stated Mr. Naoyuki Mochida, president of Mochida. “Both Mochida and Amarin have demonstrated strong capabilities in developing and commercializing EPA-based products and we believe that together we can achieve much more to improve patient care in the years to come.”
Among other terms in the agreement, Amarin obtained an exclusive license to certain Mochida intellectual property to advance Amarin’s interests in the United States and certain other territories and the parties will collaborate to research and develop new products and indications based on EPA for Amarin’s commercialization in the United States and certain other territories. The potential new product and indication opportunities contemplated under this agreement are in relatively early stages of development.
Questions for KM...
Are there to be royalties to be paid to Mochida?....Is the deal tranferable in case of a BO by a BP?